Hisun Pharmaceutical (Nantong) Co., Ltd.
Form 483 issued July 12, 2024 · Nantong, China
- Inspection
- Jul 8 – Jul 12, 2024
- Observations
- 4
- Pages
- 3
- FEI number
- 3010956224
In short: On July 12, 2024, FDA issued a Form 483 with 4 observations to Hisun Pharmaceutical (Nantong) Co., Ltd. in Nantong, Jiangsu (FEI 3010956224) after an inspection that ran Jul 8 – Jul 12, 2024. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 4 of 4 observations.
Most cited: 21 CFR 211.100 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Changes to written procedures are not reviewed and approved by…
- 02
Deviations from written process contro! procedures are…
- 03
Equipment and utensils are not cleaned or maintained at appropriate intervals to prevent contamination that would…
- 04
There is a failure to establish adequate written procedures for cleaning equipment and its release for…
This inspection in context
Questions about this 483
What did FDA find at Hisun Pharmaceutical (Nantong) Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Hisun Pharmaceutical (Nantong) Co., Ltd. inspected by FDA?
The inspection ran Jul 8 – Jul 12, 2024, and the Form 483 is dated July 12, 2024.
How do I get the full Form 483 for Hisun Pharmaceutical (Nantong) Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.